– Former Novartis and Biogen Executive Brings
Extensive Multiple Sclerosis Drug Commercialization Experience to
Immunic –
– Werner Gladdines, Current Vice President,
Program Management & Clinical Development Operations, Promoted
to Chief Development Officer –
NEW YORK,
July 9,
2024 /PRNewswire/ -- Immunic,
Inc. (Nasdaq: IMUX), a biotechnology company
developing a clinical pipeline of orally administered, small
molecule therapies for chronic inflammatory and autoimmune
diseases, today announced that seasoned biopharmaceutical
executive, Jason Tardio, will be
joining the company as Chief Operating Officer and President,
effective July 12, 2024. In the newly
created role, Mr. Tardio will lead internal efforts to prepare for
the potential launch of vidofludimus calcium (IMU-838), the
company's orally available nuclear receptor related 1 (Nurr1)
activator. Jason will also work closely with Patrick Walsh, Chief Business Officer, to
prepare the company for a range of potential partnership outcomes
for vidofludimus calcium, as well as Immunic's other drug
candidates.
"Jason's extensive experience, most notably
related to the launch and commercialization of successful multiple
sclerosis (MS) drugs for both Novartis and Biogen, as well as his
history of significant out-licensing transactions provide Immunic
with an invaluable and proven skill as we draw closer to completion
of vidofludimus calcium's phase 3 ENSURE program," stated
Daniel Vitt, Ph.D., Chief Executive
Officer of Immunic. "Jason's appointment reflects our commitment to
both commercial and partnership preparedness and comes at a
particularly important and exciting time with the upcoming read-out
of our phase 2 CALLIPER trial in progressive MS expected in
April 2025 and the completion of our
twin phase 3 ENSURE trials in relapsing MS expected in the second
quarter and the second half of 2026, respectively. We warmly
welcome him to Immunic."
Mr. Tardio added, "I am thrilled to join
Immunic's very talented team and am particularly enthusiastic about
the potential to bring such a groundbreaking and much-needed oral
treatment option to patients with relapsing and also progressive
forms of MS, where patients have few options and there continues to
be a huge unmet need. With its compelling dual mechanism of action,
as well as its combined neuroprotective, anti-inflammatory, and
antiviral effects, vidofludimus calcium has the potential to
meaningfully enhance therapeutic options and also tap enormous
markets. I look forward to applying my years of experience in this
indication to support the drug's ultimate commercial success,
assuming future regulatory approval."
Mr. Tardio most recently served as Chief
Operating Officer of Ovid Therapeutics Inc. since June 2021, after joining the company as Chief
Commercial Officer in November 2019.
While there, he led all functions of Ovid's commercial business, with an emphasis
in transitioning the company from a pre-commercial entity into a
fully integrated and program-oriented commercial enterprise.
Previously, Mr. Tardio served as Vice President, Head of the
Multiple Sclerosis Franchise at Novartis AG from September 2018 to November
2019, a business unit with annual revenues of more than
$3 billion, where he successfully
launched MAYZENT® (siponimod)* and was responsible for developing
and managing all aspects of the U.S. commercial plan, brand
P&L, strategy development and go-to-market modeling for the
Novartis MS franchise. Before Novartis, Mr. Tardio spent nine years
in positions of increasing responsibility at Biogen Inc., where he
most recently served as General Manager, Managing Director for
Biogen's Latin America South
affiliate. Earlier at Biogen, Mr. Tardio held a wide range of sales
and marketing roles, including positions in global commercial
strategy, the U.S. business unit and the international affiliates,
where he played a key role in launching both the AVONEX® PEN
(interferon beta-1a)* and PLEGRIDY® (peginterferon beta-1a)* for
relapsing forms of MS. Mr. Tardio's more than two decades of
experience in the biopharmaceutical industry began at Wyeth
Pharmaceuticals Inc. and Sepracor, Inc., with various roles in
sales, sales training and marketing. He holds a Bachelor of Science
from The College of New Jersey and an
MBA in Pharmaceutical Marketing from St. Joseph's University.
The company also reported that Werner Gladdines,
current Vice President, Program Management & Clinical
Development Operations, has been promoted to Chief Development
Officer. Mr. Gladdines joined Immunic in January 2021 as Head of the IMU-838 Program.
Since then, he has held positions of increasing responsibility and
was appointed Vice President, Program Management & Clinical
Development Operations in February
2023. In his new role as Chief Development Officer, Mr.
Gladdines will take over additional strategic and operational
responsibility for Immunic's overall clinical operations
functions.
* MAYZENT® is a registered trademark of Novartis
AG; AVONEX® and PLEGRIDY® are registered trademarks of Biogen
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing
a clinical pipeline of orally administered, small molecule
therapies for chronic inflammatory and autoimmune diseases. The
company's lead development program, vidofludimus calcium (IMU-838),
is currently in phase 3 and phase 2 clinical trials for the
treatment of relapsing and progressive multiple sclerosis,
respectively, and has shown therapeutic activity in phase 2
clinical trials in patients suffering from relapsing-remitting
multiple sclerosis, progressive multiple sclerosis and
moderate-to-severe ulcerative colitis. Vidofludimus calcium
combines neuroprotective effects, through its mechanism as a
first-in-class nuclear receptor related 1 (Nurr1) activator, with
additional anti-inflammatory and anti-viral effects, by selectively
inhibiting the enzyme dihydroorotate dehydrogenase (DHODH).
IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended
to restore intestinal barrier function and regenerate bowel
epithelium, which could potentially be applicable in numerous
gastrointestinal diseases, such as celiac disease, for which it is
currently in preparations for a phase 2 clinical trial. IMU-381,
which currently is in preclinical testing, is a next generation
molecule being developed to specifically address the needs of
gastrointestinal diseases. For further information, please visit:
www.imux.com.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains "forward-looking statements" that
involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform
Act of 1995. All statements, other than statements of historical
facts, included in this press release regarding new management
hires and promotions, strategy, future operations, future financial
position, future revenue, projected expenses, sufficiency of cash,
expected timing, development and results of clinical trials,
prospects, plans and objectives of management are forward-looking
statements. Examples of such statements include, but are not
limited to, statements relating to Immunic's development programs
and the targeted diseases; the potential for Immunic's development
programs to safely and effectively target diseases; preclinical and
clinical data for Immunic's development programs; the timing of
current and future clinical trials and anticipated clinical
milestones; the nature, strategy and focus of the company and
further updates with respect thereto; the development and
commercial potential of any product candidates of the company;
expectations regarding the capitalization, resources and ownership
structure of the company; and the executive and board structure of
the company. Immunic may not actually achieve the plans, carry out
the intentions or meet the expectations or projections disclosed in
the forward-looking statements and you should not place undue
reliance on these forward-looking statements. Such statements are
based on management's current expectations and involve substantial
risks and uncertainties. Actual results and performance could
differ materially from those projected in the forward-looking
statements as a result of many factors, including, without
limitation, the COVID-19 pandemic, increasing inflation, impacts of
the Ukraine – Russia conflict and the conflict in the
Middle East on planned and ongoing
clinical trials, risks and uncertainties associated with the
ability to project future cash utilization and reserves needed for
contingent future liabilities and business operations, the
availability of sufficient financial and other resources to meet
business objectives and operational requirements, the fact that the
results of earlier preclinical studies and clinical trials may not
be predictive of future clinical trial results, the protection and
market exclusivity provided by Immunic's intellectual property,
risks related to the drug development and the regulatory approval
process and the impact of competitive products and technological
changes. A further list and descriptions of these risks,
uncertainties and other factors can be found in the section
captioned "Risk Factors," in the company's Annual Report on Form
10-K for the fiscal year ended December 31,
2023, filed with the SEC on February
22, 2024, and in the company's subsequent filings with the
Securities and Exchange Commission. Copies of these filings are
available online at www.sec.gov or ir.imux.com/sec-filings. Any
forward-looking statement made in this release speaks only as of
the date of this release. Immunic disclaims any intent or
obligation to update these forward-looking statements to reflect
events or circumstances that exist after the date on which they
were made. Immunic expressly disclaims all liability in respect to
actions taken or not taken based on any or all the contents of this
press release.
Contact Information
Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com
US Media Contact
KOGS Communication
Edna Kaplan
+1 617 974 8659
kaplan@kogspr.com
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SOURCE Immunic, Inc.